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510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

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FDA 官方历史目录记录;Final guidance;发布日期:2024-11-21。官方主题:Premarket, 510(k), Administrative / Procedural。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov